Federal authorities have ordered a New Jersey company to destroy its unapproved products and stop further manufacturing and distributing them until the drugs receive Food and Drug Administration (FDA) approval. A federal judge from the US District Court for the Southern District of Ohio entered aconsent decree for a permanent injunction against the company, Ascend Laboratories of New Jersey. The unapproved drugs are as follows:
- Pramoxine-HC Otic Drops;
- Hydrocortisone Acetate Suppositories 25 milligrams;
- Urea Cream 39%;
- Urea Cream 40%; and
- Urea Lotion 40%
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